Eligard

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INDICATIONS

DOSAGE AND ADMINISTRATION

As with other similar agents, the use of gloves is
recommended during mixing and administration.1

ELIGARD® is administered subcutaneously and provides
continuous release of leuprolide acetate over a one-, three-, four-, or
six-month treatment period (Table 1). The injection delivers the dose of
leuprolide acetate incorporated in a polymer formulation.

Table 1: ELIGARD® Recommended Dosing

Dosage

7.5 mg

22.5 mg

30 mg

45 mg

Recommended Dose

1 injection every month

1 injection every 3 months

1 injection every 4 months

1 injection every 6 months

Once mixed, ELIGARD® should be discarded if not
administered within 30 minutes.

As with other drugs administered by subcutaneous
injection, the injection site should vary periodically. The specific injection
location chosen should be an area with sufficient soft or loose subcutaneous
tissue. In clinical trials, the injection was administered in the upper-or
mid-abdominal area. Avoid areas with brawny or fibrous subcutaneous tissue or
locations that could be rubbed or compressed (i.e., with a belt or clothing
waistband).

Mixing Procedure

IMPORTANT: Allow the product to reach room temperature
before using. Once mixed, the product must be administered within 30 minutes.

Follow the instructions as directed to ensure proper
preparation of ELIGARD® prior to administration:

ELIGARD® is packaged in either thermoformed trays or
pouches. Each carton contains:

One sterile Syringe A pre-filled with the ATRIGEL®
Delivery System

One Syringe B pre-filled with leuprolide acetate powder

One long white plunger rod for use with Syringe B

One sterile needle or One sterile safety needle

Desiccant pack(s)

1. On a clean field, open all of the packages and remove
the contents. Discard the desiccant pack(s).

Figure 1 and 2

2. Pull out the blue-tipped short plunger rod and attached
stopper from Syringe B and discard (Figure 1). Gently insert the long,
white replacement plunger rod into the gray primary stopper remaining in
Syringe B by twisting it in place (Figure 2).

4. Join the two syringes together by pushing in and twisting
until secure (Figure 5).

Figure 6

5. Inject the liquid contents of Syringe A into Syringe B
containing the leuprolide acetate. Thoroughly mix the product by pushing the
contents of both syringes back and forth between syringes (approximately 45
seconds) to obtain a uniform suspension (Figure 6). When thoroughly mixed, the
suspension will appear light tan to tan (ELIGARD® 7.5 mg) or colorless to pale
yellow (ELIGARD® , 22.5 mg, 30 mg and 45 mg) in color. Please Note: Product
must be mixed as described; shaking will not provide adequate mixing of the
product.

Figure 7

6. Hold the syringes vertically with Syringe B on the
bottom. The syringes should remain securely coupled. Draw the entire mixed
product into Syringe B (short, wide syringe) by depressing the Syringe A
plunger and slightly withdrawing the Syringe B plunger. Uncouple Syringe A
while continuing to push down on the Syringe A plunger (Figure 7). Note:
Small air bubbles will remain in the formulation – this is acceptable.

Figure 8, 9 & 10

[Applies to ELIGARD® single use kit of a two
syringe-mixing system with sterile needle]

7. Hold Syringe B upright. Remove the cap on the bottom
of the sterile needle cartridge by twisting it (Figure 8). Attach the needle
cartridge to the end of Syringe B (Figure 9) by pushing in and turning the
needle until it is firmly seated. Do not twist the needle onto the syringe
until it is stripped. Pull off the clear needle cartridge cover prior to
administration (Figure 10).

Figure 11

Figure 12

Figure 13

[Applies to ELIGARD® single use kit of a two
syringe-mixing system with sterile safety needle]

8. Hold Syringe B upright. Open the sterile safety needle
package by peeling back the paper tab and remove the safety needle (Figure 11).
Secure the needle to the end of Syringe B by holding the protective needle
sheath and twisting the syringe clockwise to fully seat the needle (Figure 12).
Remove the protective needle sheath prior to administration (Figure 13).

Administration Procedure

IMPORTANT: Allow the product to reach room temperature
before using. Once mixed, the product must be administered within 30 minutes.

1. Choose an injection site on the abdomen, upper
buttocks, or anywhere with adequate amounts of subcutaneous tissue that does
not have excessive pigment, nodules, lesions, or hair. Since you can vary the
injection site with a subcutaneous injection, choose an area that hasn't
recently been used.

2. Cleanse the injection-site area with an alcohol swab.

3. Using the thumb and forefinger of your non-dominant
hand, grab and bunch the area of skin around the injection site.

4. Using your dominant hand, insert the needle quickly at
a 90° angle. The approximate angle you use will depend on the amount and
fullness of the subcutaneous tissue and the length of the needle. After the
needle is inserted, release the skin with your nondominant hand.

5. Inject the drug using a slow, steady push. Press down
on the plunger until the syringe is empty.

6. Withdraw the needle quickly at the same angle used for
insertion.

Figure 14

or

Figure 15

or

Figure 16

Figure 17

[Step 7 only applies to ELIGARD® single use kit of a two
syringe-mixing system with sterile safety needle]

7. Immediately following the withdrawal of the needle,
activate the safety shield on the needle by using a thumb (Figure 14) or finger
(Figure 15) or a flat surface (Figure 16) to push the safety shield forward
until it completely covers the needle tip and locks into place. An audible and
tactile “click” verifies a locked position for the safety shield (Figure 17).

8. Discard all components safely in an appropriate
biohazard container.

HOW SUPPLIED

Dosage Forms And Strengths

ELIGARD® is an injectable suspension of leuprolide
acetate available in a single use kit. The kit consists of a two-syringe mixing
system, a sterile needle or a sterile safety needle (Table 2), a silica gel
desiccant pouch to control moisture uptake, and a package insert for
constitution and administration procedures. Each syringe is individually
packaged. One contains the ATRIGEL® Delivery System and the other contains
leuprolide acetate. When constituted, ELIGARD® is administered as a single
dose.

Table 2: ELIGARD® Needle specifications

ELIGARD® formulation

Sterile needle

Sterile safety needle

Gauge

Length

Gauge

Length

7.5 mg

20-gauge

1/2-inch

20-gauge

5/8-inch

22.5 mg

20-gauge

1/2-inch

20-gauge

5/8-inch

30 mg

20-gauge

5/8-inch

20-gauge

5/8-inch

45 mg

18-gauge

5/8-inch

18-gauge

5/8-inch

REFERENCES

Storage And Handling

ELIGARD® is available in a single use kit of a two
syringe-mixing system with a sterile needle in the following strengths: